Sizer Device Having a Plurality of Anterior-Posterior Ratios

ABSTRACT

Described is a device for evaluating a heart valve annulus in order to choose a particular annuloplasty device to be attached to the annulus, wherein the annuloplasty device has an inter-trigonal or inter-commissural distance and an anterior-posterior ratio, the device comprising: a valve sizing element having one of a plurality of inter-trigonal or inter-commissural distances and comprising a plurality of indicia on the valve sizing element corresponding to a plurality of anterior-posterior ratios and used to compare to the annulus in order to indicate an anterior-posterior ratio of the annulus. Adjustable devices for evaluating a plurality of anterior-posterior ratios are also described. Also, methods of sizing a patient&#39;s heart valve annulus are described.

PRIORITY

The present non-provisional patent application claims benefit from U.S.Provisional Patent Application having Ser. No. 61/062,412, filed on Jan.25, 2008, by Ryan et al., and titled SYSTEM OF ANNULOPLASTY DEVICES WITHVARYING ANTERIOR-POSTERIOR RATIOS AND RELATED DEVICES AND METHODS,wherein the entirety of said provisional patent application isincorporated herein by reference.

TECHNICAL FIELD

The present invention relates generally to devices and methods forrepair of heart valves, and more particularly to a sizer device used tosize the inter-trigonal (or inter-commissural) distance andanterior-posterior (A-P) ratio of a mitral valve annulus in order tochoose an appropriate annuloplasty device for repair of the mitralvalve.

BACKGROUND OF THE INVENTION

Heart valve disease is a widespread condition in which one or more ofthe valves of the heart fails to function properly. Various surgicaltechniques may be used to replace or repair a diseased or damaged valve.In just one way, in a valve replacement surgery, damaged leaflets of thevalve are excised and the annulus is sculpted to receive a replacementvalve. Another less drastic method for treating defective valves isrepair or reconstruction by annuloplasty, in which the valve annulus isre-shaped and held in place by attaching a prosthetic annuloplastyrepair segment or ring to an interior wall of the heart around the valveannulus. The annuloplasty ring is designed to support the functionalchanges that occur during the cardiac cycle; maintaining coaptation andvalve integrity. Annuloplasty prostheses, which can generally becategorized as either annuloplasty rings or annuloplasty bands, areemployed in conjunction with valvular reconstructive surgery to assistin the correction of heart valve defects such as stenosis and valvularinsufficiency.

One type of valvular insufficiency is ischemic mitral regurgitation(IMR). In IMR, the coordination of the mitral leaflets, the mitralannulus, the subvalvular apparatus and the left ventricular wall isupset in some way. There are many causes, such as congenital defects,rheumatic fever, endocarditis, etc. There is a classification system forIMR, which was developed by Carpentier. IMR is classified as either TypeI, II, IIIa or IIIb, based mainly on leaflet motion.

The effects of valvular dysfunction vary, with IMR typically having moresevere physiological consequences to the patient than tricuspid valveregurgitation. In either area of the heart, however, many of the defectsare associated with dilation of the valve annulus. This dilation notonly prevents competence of the valve but also results in distortion ofthe normal shape of the valve orifice. Remodeling of the annulus istherefore central to most reconstructive procedures on the valves.Clinical experience has shown that repair of the valves, whentechnically possible, produces better long-term results than valvereplacement.

With regard to the mitral valve, many procedures have been described tocorrect the pathology of the valve leaflets and their associated chordaetendinae and papillary muscles. The mitral valve, in particular, is abicuspid valve having a posterior leaflet that has an annulus insertionlength that is larger than that of an anterior leaflet, which coapts ormeets with the posterior leaflet. The part of the mitral valve annulusthat is attached to the anterior leaflet is called the anterior aspect,while the part attached to the posterior leaflet is called the posterioraspect. The two leaflets are fused at two commissures that are insertedin the annulus just below the level of two cardiac trigones, called theanterolateral trigone and the posterolateral trigone.

In mitral valve repair, coaptation of the posterior and anteriorleaflets is important. Also, it is considered important to preserve thenormal distance between the two trigones. A significant surgicaldiminution of the inter-trigonal distance may cause left ventricularoutflow obstruction and/or distortion of the base of the aortic valve.Thus, it is desirable to maintain the natural inter-trigonal distanceand shape following mitral valve repair surgery.

Mitral valve annulus dilation tends to be confined to the posterioraspect, resulting in a posterior aspect that is larger than normal.Consequently, the repair of mitral valve annulus dilation generallyinvolves reducing the size of the posterior aspect.

In the repair of mitral valve annulus dilation, the associated procedurebegins with identification of the trigones. The distance between thetrigones (i.e., inter-trigonal distance) remains practically constantduring the cardiac cycle in any one particular patient, but may varyfrom 24 to 40 mm in length in patients. Annuloplasty devices used totreat mitral valve dilation are available in different sizes based uponthe distance between the trigones along the anterior aspect (i.e., theaortic curtain), which is generally in even 2 mm increments from about24 mm to about 40 mm. It is critical to the successful outcome of theannuloplasty procedure to accurately determine the size, i.e.,inter-trigonal distance, of the annulus.

There are existing sizer devices used to determine the size (i.e.,inter-trigonal distance) of the annulus. Valve sizers, which resemblethe shape of the valve annulus, are generally provided in various sizes.A surgeon estimates the native valve annulus size and selects a sizeraccordingly. The sizer is attached to the end of the handle and guidedinto proximity of the annulus. If the sizer is not the appropriate size,it is withdrawn, detached from the handle, and replaced by a differentsizer. Once the size of the annulus has been determined, a properlysized valve or annuloplasty ring or band may be selected and implanted.

Annuloplasty devices for mitral valve repair have generally beenconfigured to restore the original, healthy shape of the mitral annulusat the end of systole. The device is typically semi-rigid, planar andrestores the primary anterior-posterior (A-P) dimension or ratio of themitral valve annulus. The device typically allows for sufficientcoaptation of the leaflets at the end of systole to correct and/orprevent valvular insufficiency.

For a given size of valve annulus, there may be a plurality of possibletypes of annuloplasty devices that may be implanted. The choice ofdevice will depend upon the disease state or physiological problemassociated with the valve. For example, with Barlow's disease, excessmitral valve leaflet tissue in the anterior portion exists, which causesthe mitral valve to leak back into the left atrium. Thus, with Barlow'sdisease, for example, an annuloplasty device having a design thataccommodates excess leaflet tissue is desired. For example, a devicehaving a longer anterior dimension (i.e., a larger A-P ratio) thanstandard devices may be used.

There is a continued desire to be able to improve annuloplasty devicesto accommodate different physical structures of the heart due todifferent disease states of the heart. In addition, there is also a needfor sizers to determine which size and type of device to use in aparticular valve annulus.

SUMMARY OF THE INVENTION

The present invention generally involves sizer devices used to size theinter-trigonal (or inter-commissural) distance and theanterior-posterior (A-P) ratio of a mitral valve annulus in order tochoose an appropriate annuloplasty device for repair of the mitralvalve. In particular, the present invention is a sizer device that fitsone of a plurality of sizes of annulus, i.e., one inter-trigonal (orinter-commissural) distance. The sizer device is also able to measurethe anterior-posterior (A-P) ratio of the annulus. Preferably, eachsizer device, having a specific inter-trigonal distance or size, cansize an annulus for a plurality of different A-P ratios. Mostpreferably, the sizer device can evaluate the annulus with regard tothree specific A-P ratios (e.g., about 0.6, about 0.75 and about 0.85).The three specific A-P ratios may preferably correspond to threecategories of devices that are available to a surgeon in a set ofannuloplasty devices, for example. It is contemplated, however, that thesizer device of the present invention may size or evaluate other valves,other A-P ratios, and may be used to size the annulus for various typesof annuloplasty devices.

Embodiments of the present invention offer advantages. The sizer deviceof the present invention allows for sizing the A-P ratio of a valveannulus without having to use multiple sizer devices. A single sizerwould replace multiple sizers that would normally be needed. The sizerdevice includes means for measuring, or evaluating the annulus withregard to, at least two different A-P ratios, but preferably at leastthree different A-P ratios. The sizer device therefore allows for easierand more efficient sizing of the annulus. There will be less proceduraltime necessary because changing out the sizers will not be necessary.Also, a lower cost may be associated with the invention since there willbe smaller packaging necessary to house the sizer device rather thanmultiple devices.

A first aspect of the present invention is a device for evaluating aheart valve annulus in order to choose a particular annuloplasty deviceto be attached to the annulus. Each annuloplasty device has aninter-trigonal (or inter-commissural) distance and an anterior-posteriorratio. One embodiment of the device comprises: a valve sizing elementhaving one of a plurality of inter-trigonal (or inter-commissural)distances and comprising a plurality of indicia on the valve sizingelement corresponding to a plurality of anterior-posterior ratios,wherein the indicia are compared to the annulus in order to indicate ananterior-posterior ratio of the annulus. The device may further comprisean elongate element having a proximal end and a distal end, wherein thevalve sizing element is coupled to the distal end of the elongateelement. The valve sizing element may comprise an optically transparentmaterial. The indicia may comprise markings on at least one surface ofthe valve sizing element. The markings may comprise visible markingsimprinted on the at least one surface of the valve sizing element. Theindicia may comprise a plurality of generally semi-circular-shaped ribsthat are arranged concentrically along a surface of the valve sizingelement. The indicia may comprise steps in a surface of the valve sizingelement that are arranged generally concentrically and are generallysemi-circular in shape.

A second aspect of the present invention is an adjustable device forevaluating a heart valve annulus in order to choose a particularannuloplasty device to be attached to the annulus. One embodiment of thedevice may comprise: a valve sizing element comprising first and secondportions and means for moving the portions with respect to one anotherin order to provide the valve sizing element with one of a plurality ofanterior-posterior ratios. The device may further comprise an elongateelement having a proximal end and a distal end, wherein the valve sizingelement is coupled to the distal end of the elongate element, and theelongate element may comprise means for controlling the movement of thefirst and second portions. A second embodiment of the adjustable devicemay comprise: a valve sizing element comprising: a plate having a firstportion and a second portion; two arms comprising a center and two ends,the two arms connected to each other by an element near the center ofeach arm and connected to the first and second portions near the ends ofthe arms, wherein angular movement of the arms with respect to oneanother causes distance between the first and second portions of theplate to be varied resulting in a device having a plurality ofanterior-posterior ratios. The valve sizing element may comprise indiciacorresponding to the plurality of anterior-posterior ratios. The indiciamay comprise visible markings imprinted on a surface of the valve sizingelement, and ends of the arms are located near the markings in order toindicate an anterior-posterior ratio of the device corresponding to aparticular configuration of the arms and plate portions. The device mayfurther comprise an elongate element having a proximal end and a distalend, wherein the valve sizing element is coupled to the distal end ofthe elongate element, and angular movement of the two arms is caused byrotation of the elongate element with respect to the valve sizingelement. A third embodiment of the adjustable device comprises: anelongate element having a proximal end and a distal end; a valve sizingelement attached to the distal end of the elongate element, the valvesizing element comprising: a plate; and a flange extending from theplate and slidably disposed within the plate; and means for extendingthe flange from the plate of the valve sizing element that are remotelycontrolled from the proximal end of the elongate element. The means forextending and retracting the flange may comprise a first wire and asecond wire in tension, and the first wire may act to extend the flangefrom the sizing plate and the second wire may act to retract the flangeinto the sizing plate. The first and second wires may extend to theproximal end of the elongate element where they are attached to a tabthat is moved distally or proximally in the proximal end in order tomove the wires.

A third aspect of the present invention is a method of sizing apatient's heart valve annulus. One embodiment comprises the steps of:receiving a device comprising a valve sizing element having one of aplurality of inter-trigonal distances and comprising a plurality ofindicia on the valve sizing element corresponding to a plurality ofanterior-posterior ratios; inserting the adjustable device into thepatient such that the valve sizing element is positioned in the valveannulus; adjusting the valve sizing element so that the valve sizingelement contacts the valve annulus; comparing the indicia on the valvesizing element to the valve annulus; determining the anterior-posteriorratio of the annulus; and removing the valve sizing element from thepatient. A second embodiment comprises the steps of: receiving anadjustable device for evaluating a heart valve annulus in order tochoose a particular annuloplasty device to be attached to the annulus,the device comprising: a valve sizing element comprising first andsecond portions and means for moving the portions with respect to oneanother in order to adjust the valve sizing element to have one of aplurality of different anterior-posterior ratios; inserting theadjustable device into the patient such that the valve sizing element ispositioned in the valve annulus; adjusting the valve sizing element sothat the valve sizing element contacts the valve annulus; determiningthe anterior-posterior ratio of the annulus; and removing the valvesizing element from the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be further explained with reference to theappended Figures, wherein:

FIG. 1 is a perspective view of one embodiment of a sizer device inaccordance with the present invention;

FIG. 2 is a front view of a sizing plate of another embodiment of asizer device in accordance with the present invention;

FIG. 3 is a side view of the sizing plate of FIG. 2;

FIGS. 4-6 are front views of a sizing plate of another embodiment of asizer device in accordance with the present invention, which is shown inthree different configurations (one in each FIG.) corresponding to threedifferent A-P ratios;

FIGS. 7-9 are perspective views of another embodiment of a sizer devicein accordance with the present invention, which is shown in threedifferent configurations (one in each FIG.) corresponding to threedifferent A-P ratios;

FIG. 10 includes a cut-away view of a handle portion of the sizer deviceof FIGS. 7-9; and

FIG. 11 is a see-through view of a sizer plate portion of the sizerdevice of FIGS. 7-9.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

With reference to the accompanying figures, wherein like components arelabeled with like numerals throughout the several figures, a sizerdevice that is able to size a valve annulus for an inter-trigonaldistance (or inter-commissural distance) and varying A-P ratios isdisclosed, taught and suggested. The inter-trigonal (orinter-commissural) distance and A-P ratio of a mitral valve annulus ispreferred to be measured in order to be able to choose an appropriateannuloplasty device for repair of a mitral valve.

In particular, the sizer device of the present invention will correspondto one of a plurality of possible sizes of annulus, i.e. inter-trigonalor inter-commissural distances. The sizer device will also be capable ofsizing the annulus for (i.e., comparing the annulus to) at least twodifferent A-P ratios. A purpose of the sizer device including varyingA-P ratios is to allow a surgeon to size a particular valve annulus fora plurality of different A-P ratios using only one device. Different A-Pratios in annuli having the same inter-trigonal (or inter-commissural)distance may be due to different disease states of the valves, forexample. Thus, a surgeon may measure both inter-trigonal (orinter-commissural) distance and A-P ratio in one device, allowing for anefficient and effective evaluation of the annulus. Preferably, thesurgeon has a set of devices with different A-P ratios, and possiblydifferent designs, available for each inter-trigonal (orinter-commissural) distance, or size, of annulus. The surgeon may thenchoose the appropriate device from the set in order to address theparticular concerns with the annulus. Advantageously, the presentinvention provides the surgeon the ability to more specifically addressa problem with a particular valve annulus.

For each size, or inter-trigonal (or inter-commissural) distance, ofsizer device there are a plurality of A-P ratios that may be tested,sized, or evaluated. Preferably, the number of A-P ratios that may betested by the device is three. The plurality of A-P ratios preferablycorrespond to different types or categories of annuloplasty devices. Forinstance, the A-P ratios may correspond to three different categories ofdevices that are designed to address different problems, pathologies,disease states, etc., relating to the heart. One category is preferablya remodeling (restorative) category that has a traditional annuloplastydevice design, which reshapes the annulus that generally has a dilatedposterior annulus. The remodeling (restorative) category of devices ispreferably designed to address degenerative heart disease, myxomatousdegeneration, fibroelastic deficiency, types I and II IMR, anddegenerative diseases which result in a dilated posterior annulus, forexamples. Another category is a restrictive category of devices, whichis preferably designed to address cardiac ischemia, dilatedcardiomyopathy, tethered leaflets in secondary mitral valveinsufficiency, and Type IIIb IMR, for examples. And, a third category isan enlarging category of devices that is preferably designed to addressBarlow's syndrome, systolic anterior motion (SAM) in Myxoid HeartDisease, septal hypertrophy, and Type II IMR, for examples. It iscontemplated, however, that the set of devices may include additionaltypes of devices that address additional or alternative heartconditions.

The present invention is described herein with regard to the treatingthe mitral valve of the heart. However, it is contemplated that thepresent invention may also apply to other valves of the heart (e.g., thetricuspid valve). Therefore, the categories and types of annuloplastydevices that the present invention may be used to size for may also bedifferent than those specifically described herein.

One exemplary embodiment of the present invention is shown in FIG. 1.FIG. 1 shows a perspective view of a sizer device 100 comprising anelongate segment 110 with first 112 and second 114 ends. A valve sizer120 is attached to the first end 112 of the elongate segment 110. Thepurpose of the valve sizer 120 as shown is to size a mitral valveannulus in particular. Although, it is contemplated that the presentinvention may include sizers that size other valves besides the mitralvalve.

The purpose of the elongate segment 110 is to deliver the valve sizer120 adjacent or near the valve annulus being sized. The surgeonperforming the sizing may hold the device 100 from outside of apatient's body. The elongate segment 110 may comprise a metal wire.However, the present invention is not limited to the use of metal wirefor the elongate segment 110, and other materials are also contemplated.

The elongate segment 110 also preferably includes a handle 116 on thesecond end 114 of the elongate segment 110. The handle 116 is optional,but is preferred in order for the sizer device 100 to be handled moreeasily. The handle 116 is shown with optional bevels 118 on the outersurface, in order to allow for better gripping of the device 100 by auser. The handle 116 is preferably comprised of a polymeric material.However, other materials are also contemplated.

The valve sizer 120 comprises a sizing plate 122 and an attachment hub124. The attachment hub 124 includes a socket 126 into which theelongate segment 110 of the device 100 extends and is secured. In theembodiment shown in FIG. 1, the elongate segment 110 is permanentlyadhered or secured to the valve sizer 120. However, it is alsocontemplated that the valve sizer 120 may be configured to be releasablyattached to the elongate segment 110. For example, the valve sizer 120may be snap-fit onto the elongate segment 110 or threaded onto theelongate segment 110, or attached by any other such attachment means.

The sizing plate 122 of the valve sizer 120 may have one of a pluralityof possible two-dimensional (2D) and three-dimensional (3D) shapes. Theshape of the sizing plate 122 depends upon, e.g., the type of valvebeing sized, the disease state of the valve, the shape of acorresponding annuloplasty device, etc. For example, the sizing plate122 may be planar or saddle-shaped.

The sizing plate 122 is preferably made from biocompatible material thatis also preferably optically transparent and rigid to the degree that itmaintains a shape. The material could, however, have a degree ofdeformability to minimize tissue trauma while introducing the sizerthrough the surgical incision site. An exemplary material for the sizingplate 122 is polysulfone or another similar thermoplastic. However,other materials are also contemplated.

As shown in FIG. 1, the valve sizer 120 includes markings 128 on thesizing plate 122. In particular, the markings 128 shown indicatedifferent A-P ratios. The markings 128 are used by a surgeon sizing avalve annulus in order to determine which A-P ratio best accommodatesthe annulus. The surgeon can preferably see through the sizing plate 122in order to determine which A-P ratio best corresponds to the valveannulus. The markings 128 shown are letters, e.g., A, B, C, and lines,however, other similar markings are also contemplated, such as words,symbols, etc.

The thickness of the sizing plate 122 of the sizer 120 is preferablyminimized while still retaining substantial strength to preventsubstantial flexing or bending or to prevent breakage. The thickness isminimized in order to prevent optical distortion through the sizingplate 122 and/or in order to allow the sizing plate 122 to fit throughrelatively small openings, such as an annulus.

The sizing plate 122 is shown having a continuous surface. However, theplate 122 may alternatively be discontinuous and may include voids.

Another embodiment of sizer device of the present invention is shown inFIGS. 2 and 3. Similar to sizer device 100 described above, sizer device200 comprises an elongate segment 210 with first 212 and second 214ends, a handle 216 on second end 214 of elongate segment 210, and avalve sizer 220 (FIG. 2) that includes a sizing plate 222 and anattachment hub 224.

The description of the components as provided with regard to sizerdevice 100 preferably generally also applies to similar components ofsizer device 200. The sizing plate 222 is preferably used to size anddetermine the A-P ratio of a mitral valve annulus, although theinvention contemplates other valves as well. The elongate segment 210and handle 216, as well as the means for attaching the elongate segment210 to the valve sizer 220 are similar to those components of sizerdevice 100. The sizing plate 222 is preferably rigid and preferably madeof an optically transparent material.

FIG. 2 shows a front view of the valve sizer 220 with markings 228denoting three different A-P ratios (indicated as A, B, C), just as insizer device 100. Other markings are also contemplated, as with sizerdevice 100.

The side view in FIG. 3 shows that the sizing plate 222 is differentfrom sizing plate 122 in FIG. 1. Sizing plate 222 is preferably stepped(with steps marked as 230) relating to multiple, different A-P ratios.The steps 230 are located on the side of the sizing plate 222 with theattachment hub 224 in FIG. 3. However, the steps 230 could alternativelybe located on the opposite side of the sizing plate 222. The purpose ofthe steps 230 is for the surgeon to be able to position the sizing plate222 directly in the valve annulus and in contact with the circumferenceof the valve annulus. The benefit of fitting the annulus around one ofthe steps 230 of the device is to get a more accurate measurement of theannulus. Also, depending upon which of the steps 230 that the annulusmost closely surrounds, the approximate A-P ratio of the annulus isdetermined.

In sizer device 200, sizing plate 222 includes optional cut-out segmentsor notches 232 that may be used as left and right trigone positionidentifiers. When using the sizer device 200 to size a valve annulus,the surgeon inserts the sizer device 200 adjacent a valve annulus and,first, checks the inter-trigonal distance. The user may check thedistance by determining if the cut-out segments 232 line up with theleft and right trigones of the annulus. The inter-trigonal distancedetermines the size of the valve sizer 220. Alternatively, thecommissures on the annulus are used to determine the size, which iscalled the inter-commissural distance.

Different sizes of valve sizers 220 may be released and attached to theelongate segment 210. Once the correct size of valve sizer 220 ischosen, the surgeon may then see whether the posterior aspect of thevalve annulus coordinates or lines up with one of the markings (A, B orC) 228 or steps 230 corresponding to a particular A-P ratio. Anannuloplasty device with a size and A-P ratio substantially identical tothat of the sizer device 200 is then preferably chosen and implanted.

Although the trigones may be used to determine the size of the annulus,as described above, there are other methods for determining the size.For example, the two valve commissures (posterior and anterior), whichdefine a distinct region where the anterior and posterior leaflets cometogether at their insertion into the annulus, may alternatively be usedto determine the size of the annulus.

Only three potential A-P ratios are represented in sizer device 200.However, it is contemplated that a different number of and different A-Pratios may be used in the device 200. Also, the sizer device 200 shownis merely representative of many different contemplated sizes and shapesof sizer devices that are in accordance with the present invention.

Another embodiment of the present invention is shown in FIGS. 4-6 invarying 20 configurations. A sizer device, of which only the valve sizer420 is shown, is used for sizing annuli of various A-P ratios. FIGS. 4-6show the valve sizer 420 in three different configurations correspondingto three different A-P ratios (A, B, and C). Most of the description ofthe components, as provided with regard to sizer device 100, preferablygenerally also applies to corresponding components of valve sizer 420.

The valve sizer 420, however, comprises a sizing plate 422 thatcomprises two segments (anterior 421 and posterior 423). The two sizingplate segments 421, 423 are extendably connected using componentsallowing the segments 421, 423 to be separated or brought together toallow the sizing plate 422 to correspond to a mitral valve annulushaving one of various A-P ratios. In particular, FIGS. 4-6 show threepossible A-P ratios, but other A-P ratios are also contemplated by thepresent invention.

As shown in FIGS. 4-6, the components of valve sizer 420 shown allow thetwo segments 421, 423 to move relative to one another and to obtainpositioning for the sizing plate 422 to obtain different A-P ratios.Such components comprise first and second arms 470, 472 rotatablyconnected near the middle of both arms 470, 472 by a pin 474. The arms470, 472 preferably are controlled by direct manipulation. However, itis also contemplated that the pin 474 could possibly be remotelycontrolled by an attached handle, for example.

Other configurations allowing for remotely controlling the movement ofarms 470, 472 are also possible.

When the pin 474 is rotated, the two arms 470, 472 rotate with respectto each other around the pin 474. Also, the rotation causes ends of thearms 470, 472 located in the posterior segment 423 of the sizing plate422 to slide in channels 478 and either pull the two sizing platesegments 470, 472 towards each other or push them apart. Preferably,there is an alignment plate 480 on the back side of plates 421, 423, asin FIGS. 4-6, that keeps the plates 421, 423 in alignment duringrotation of arms 470, 472. Preferably, the alignment plate 480 isattached to plate 421 and slidable behind plate 423. Otherconfigurations are also contemplated, however. For example, alignmentplate 423 could be guided within ribs on the back side of plate 423.

Markings 428 (e.g., A, B, C) may be provided or printed on the sizerplate 422 to indicate the A-P ratios. The arms 470, 472 may preferablyline up with the markings 428 depending on the rotation and separationof the anterior and posterior segments 421, 423 as it corresponds to thesizing plate 422 as a whole having a particular A-P ratio.

When using the valve sizer 420 to size a valve annulus, the user insertsthe valve sizer 420 adjacent a valve annulus and, first, checks theinter-trigonal distance. The user may check the distance by determiningif cut-out segments or notches 432 corresponding to the left and righttrigones line up with the left and right trigones of the annulus. Theinter-trigonal distance determines the size of the valve sizer 420 touse. Once the inter-trigonal distance of the valve sizer 420 is correct,the surgeon may then rotate the pin 474 by rotating a handle portion(not shown) attached to the pin 474. The segments 421, 423 may then movewith respect to one another in order to allow until the perimeter of thesizing plate 422 to be fit to 30 match with the annulus being measured.The arms 470, 472 may line up with a marking 428 (e.g., A, B or C) inorder to indicate the A-P ratio of the annulus. An annuloplasty devicewith a size and an A-P ratio substantially matching that of the valvesizer 420 is then preferably chosen and implanted.

Only three potential A-P ratios are represented on valve sizer 420.However, it is contemplated that a different number of and different A-Pratios may be included on the valve sizer 420. The valve sizer 420 shownis also merely representative of many different contemplated sizes andshapes of valve sizers that are possible.

Yet another embodiment of the present invention is shown in FIGS. 7-11.Sizer device 700 shown comprises an elongate segment 710 with first 712and second 714 ends, a handle 716 attached to the second end of elongatesegment 710, and a valve sizer 720 attached to the first end 712. Thevalve sizer 720 comprises a sizing plate 722, and an attachment hub 724.The sizing plate 722 includes a flange 782 that is slidably disposed inthe remainder of the sizing plate 722 and may be extended out of orretracted into the remainder of the sizing plate 722 in order to providethe sizing plate 722 with one of various A-P ratios (e.g., three in theembodiment shown in the figures). The flange 782 includes two struts 784that are slidably disposed in channels 786 (FIGS. 8, 9) in sizing plate722 in order to allow the flange 782 to move relative to the remainderof the valve sizer 720. The sizing plate 722 may include windows orcut-out portions 788 that allow for markings (e.g., A, B, C, as shown)on the struts 784 to show through to indicate a particular A-P ratiothat corresponds to the sizing plate 722 in that configuration.

The handle 716 shown includes one exemplary means for remotelycontrolling the movement of the flange 782. The handle 716 preferablycomprises a cylindrically-shaped housing 790, including an elongatedslot 792 in the housing 790. A push tab 794 extends out through theelongated slot 792 to provide a means for remotely extending the flange782 from, and retracting the flange 782 into, the remainder of thesizing plate 722. Push tab 794 may be moved proximally and distallyalong the slot 792 in order to control the movement of the flange 782.Push tab also includes a portion inside the housing 790, which is alower element 795 of push tab 794. The lower element 795 is where wires796, 797 are preferably attached to the push tab 794 in order toremotely control the flange 782.

Preferably, the push tab 794 pulls on at least one wire, but preferably(and as shown) there are two wires 796, 797 being acted upon by the pushtab 794. Depending upon which wire 796, 797 is pulled by the push tab794, the attached flange 782 is either extended or retracted in order tomove the flange 782, and provide the sizing plate 722 with a specificA-P ratio.

The wires 796, 797 preferably comprise a material that is strong enoughto move the flange 782, and in particular strong enough to pull onportions of the flange 782. Exemplary materials include, but are notlimited to, braided stainless steel, nickel alloys, Nitinol™, suture, orsuitable polymers. Preferably, the flange 782 is in constant tensionwith the wires 796, 797. Therefore, the wire material needs to be strongenough to withstand such tension.

FIGS. 10 and 11 illustrate one exemplary configuration of the componentsinside of the handle 716 and the sizing plate 722, which are used tocontrol the movement of the flange 782, in particular. However, otherconfigurations and methods for moving the flange 782 are alsocontemplated. With regard to FIG. 10, preferably, two wires 796 and 797are attached to the lower element 795 of push tab 794. Thus, for examplemovement of the tab 794 distally pulls on wire 796, and movement of tab794 proximally pulls on wire 797, or vice versa. Preferably, the wires796, 797 are in constant tension in order to extend and retract theflange 782.

FIG. 11 illustrates that the two wires 796, 797 are attached todifferent portions of the flange 782 in order to extend and retract theflange 782. As shown, wire 796 is attached to the bottom portion offlange 782 at lower attachment point 783, and wire 797 is attached toone strut 784 of the flange 782 at upper attachment point 785.Therefore, as shown, moving push tab 794 proximally could possibly pullwire 797 and extend flange 782. As shown in FIG. 11, wire 797 ispreferably attached to flange 782 at upper attachment point 785 and isrouted through the sizing plate 722 as shown. By pulling the wire 797proximally, the wire 797 located at upper attachment point 785 wouldpull downward (in figure) on strut 784 of flange 782 and would extendthe flange 782. Also, as shown, pushing the tab 794 distally may pullwire 796 such that the flange 782 is pulled upward or inward at lowerattachment point 783 from an extended position to a retracted position.Other configurations and resulting control of the flange 782 by thewires 796, 797 is also contemplated, however. Also, it is contemplatedthat a different number of wires or means other than wires may be usedto extend and retract the flange 782.

Other configurations of the sizer device 700 are contemplated by thepresent invention. The device 700 may alternatively include other meansfor extending and retracting the flange 782. Alternatively, the device700 may include a rigid rod for extending and retracting the flange 782,rather than flexible wires 796, 797. For example, such a rigid rod, oractuator shaft, could be moved proximally or distally by twisting of athreaded handle component at the proximal end of the device, which inturn could moved the flange 782. Other contemplated means for moving theflange include, but are not limited to, an actuator knob, an actuatortrigger, or an actuating handle that can be squeezed. Also, lockingfeatures may be implemented in all such contemplated means for movingthe flange 782, in order to retain the flange 782 in either a desiredextended or retracted position.

Also, the device 700 may include a tactile feedback feature, as well asvisual identification, shown in FIGS. 8-10, to notify the user of theA-P ratio. Another possible feedback mechanism may be audible.

When using the sizer device 700 to size a valve annulus, the userinserts the sizing plate 722 adjacent a valve annulus and, first, checksthe inter-trigonal (or inter-commissural) distance. The inter-trigonal(or inter-commissural) distance determines the size of the sizer device700. Once the inter-trigonal distance of the sizer device 700 iscorrect, the user may then move the push tab button 794 on the handle716 until the perimeter of the sizing plate 722 (with flange portion782) generally fits the annulus being measured. An indicator of sometype may indicate the A-P ratio of the annulus (e.g., A, B, C showingthough orifices 788). A device with a size and A-P ratio substantiallyidentical to that of the sizer device 700 is then chosen and implanted.

Only three potential A-P ratios are represented in sizer device 700.However, it is contemplated that a different number of and different A-Pratios may be included on the device 700. The sizer device 700 shown ismerely representative of many different contemplated sizes and shapes ofsizer devices.

It is to be understood that while particular embodiments of theinvention have been illustrated for use in typical valve repairprocedures, various modifications to shape, and arrangement of parts canbe made as may be desirable for varying applications as may relate tovalve sizes or later developed techniques. The invention should not beconsidered limited to the specific methods and devices preciselydescribed herein. On the contrary, various modifications will beapparent to those of ordinary skill upon reading the disclosure.Although certain embodiments are described with reference to the mitralvalve, use with other valves or anatomical structures is alsocontemplated. The foregoing detailed description has been given forclarity of understanding only. No unnecessary limitations are to beunderstood there from. The entire disclosure of any article, patent orpatent application identified herein is hereby incorporated byreference.

1. A device for evaluating a heart valve annulus in order to choose aparticular annuloplasty device to be attached to the annulus, whereinthe annuloplasty device has an inter-trigonal or inter-commissuraldistance and an anterior-posterior ratio, the device comprising: a valvesizing element having one of a plurality of inter-trigonal orinter-commissural distances and comprising a plurality of indicia on thevalve sizing element corresponding to a plurality of anterior-posteriorratios, wherein the indicia are compared to the annulus in order toindicate an anterior-posterior ratio of the annulus.
 2. The device ofclaim 1, further comprising an elongate element having a proximal endand a distal end, wherein the valve sizing element is coupled to thedistal end of the elongate element.
 3. The device of claim 1, whereinthe valve sizing element comprises an optically transparent material. 4.The device of claim 1, wherein the indicia comprising markings on atleast one surface of the valve sizing element.
 5. The device of claim 4,wherein the markings comprise visible markings imprinted on the at leastone surface of the valve sizing element.
 6. The device of claim 1,wherein the indicia comprise a plurality of generallysemi-circular-shaped ribs that are arranged concentrically along asurface of the valve sizing element.
 7. The device of claim 1, whereinthe indicia comprise steps in a surface of the valve sizing element thatare arranged generally concentrically and are generally semi-circular inshape.
 8. An adjustable device for evaluating a heart valve annulus inorder to choose a particular annuloplasty device to be attached to theannulus, the device comprising: a valve sizing element comprising firstand second portions and means for moving the portions with respect toone another in order to provide the valve sizing element with one of aplurality of anterior-posterior ratios.
 9. The adjustable device ofclaim 8, further comprising an elongate element having a proximal endand a distal end, wherein the valve sizing element is coupled to thedistal end of the elongate element, and the elongate element comprisesmeans for controlling the movement of the first and second portions. 10.An adjustable device for evaluating a heart valve annulus in order tochoose a particular annuloplasty device to be attached to the annulus,the adjustable device comprising: a valve sizing element comprising: aplate having a first portion and a second portion; two arms comprising acenter and two ends, the two arms connected to each other by an elementnear the center of each arm and connected to the first and secondportions near the ends of the arms, wherein angular movement of the armswith respect to one another causes distance between the first and secondportions of the plate to be varied resulting in a device having aplurality of anterior-posterior ratios.
 11. The adjustable device ofclaim 10, wherein the valve sizing element comprises indiciacorresponding to the plurality of anterior-posterior ratios.
 12. Theadjustable device of claim 11, wherein the indicia comprise visiblemarkings imprinted on a surface of the valve sizing element, and ends ofthe arms are located near the markings in order to indicate ananterior-posterior ratio of the device corresponding to a particularconfiguration of the arms and plate portions.
 13. The device of claim10, further comprising an elongate element having a proximal end and adistal end, wherein the valve sizing element is coupled to the distalend of the elongate element, and angular movement of the two arms iscaused by rotation of the elongate element with respect to the valvesizing element.
 14. An adjustable device for evaluating a heart valveannulus in order to choose a particular annuloplasty device to beattached to the annulus, the adjustable device comprising: an elongateelement having a proximal end and a distal end; a valve sizing elementattached to the distal end of the elongate element, the valve sizingelement comprising: a plate; and a flange extending from the plate andslidably disposed within the plate; and means for extending the flangefrom and retracting the flange into the plate of the valve sizingelement that are remotely controlled from the proximal end of theelongate element.
 15. The adjustable device of claim 14, wherein themeans for extending and retracting the flange comprises a first wire anda second wire in tension, and the first wire acts to extend the flangefrom the sizing plate and the second wire acts to retract the flangeinto the sizing plate.
 16. The adjustable device of claim 15, whereinthe first and second wires extend to the proximal end of the elongateelement where they are attached to a tab that is moved distally orproximally in the proximal end in order to move the wires.
 17. A methodof sizing a patient's heart valve annulus, comprising the steps of:receiving a device comprising a valve sizing element having one of aplurality of inter-trigonal or inter-commissural distances andcomprising a plurality of indicia on the valve sizing elementcorresponding to a plurality of anterior-posterior ratios; inserting theadjustable device into the patient so that the valve sizing element ispositioned in the valve annulus; adjusting the valve sizing element suchthat the valve sizing element contacts the valve annulus; comparing theindicia on the valve sizing element to the valve annulus; determiningthe anterior-posterior ratio of the annulus; and removing the valvesizing element from the patient.
 18. A method of sizing a patient'sheart valve annulus, comprising the steps of: receiving an adjustabledevice for evaluating a heart valve annulus in order to choose aparticular annuloplasty device to be attached to the annulus, the devicecomprising: a valve sizing element comprising first and second portionsand means for moving the portions with respect to one another in orderto adjust the valve sizing element to have one of a plurality ofdifferent anterior-posterior ratios; inserting the adjustable deviceinto the patient so that the valve sizing element is positioned in thevalve annulus; adjusting the valve sizing element such that the valvesizing element contacts the valve annulus; determining theanterior-posterior ratio of the annulus; and removing the valve sizingelement from the patient.